Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma

Gastric Cancer Clinical Trial

Official title:

A Phase II, Multicenter, Open-Label, Single Arm Study of Oral Infigratinib Monotherapy in Patients With Locally Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma, Who Harboring FGFR2 Gene Amplification

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06206278
• Other study ID #: LB1001-203
• Status: Recruiting
• Phase: Phase 2
• Start date: October 19, 2023
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: LianBio LLC
• Contact: Lei Mu
• Phone: +86-021-23081188
• Email: Lei.mu[@]lianbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, open-label, single arm phase II study to evaluate the efficacy and safety of Infigratinib in patients with locally advanced or metastatic GC or GEJ patient with FGFR2 gene amplification, who have failed at least 2 lines of previous standard systemic treatment .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 18 years and older

• Histologically or cytologically confirmed locally advanced or metastatic gastric adenocarcinoma, or gastroesophageal junction adenocarcinoma.

• Failed at least 2 lines of prior systemic therapy

• Willing to undergo tumor biopsy or provide FFPE samples for central lab testing.

• At least one measurable tumor lesion by RECIST v1.1

• Eastern cooperative oncology group (ECOG) performance status of 0 or 1.

• Life expectancy =3 months.

• Willing to participate in this study and sign informed consent form, able to read and understand the study, follow the procedures.

Exclusion Criteria:

• History of other primary malignancies within 3 years except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin or any other curatively treated malignancy that is not expected to require treatment for recurrence during the study.

• Previous or current treatment of a mitogen-activated protein kinase (MAPK-MEK) or selective FGFR inhibitor.

• Any known hypersensitivity to infigratinib or its excipients.

• History and/or current evidence of extensive tissue calcification.

• Current evidence of endocrine alterations of calcium/phosphate homeostasis.

• Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib (such as, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).14. Laboratory abnormality as defined in protocol.

• Considered unsuitable to participate in the study by Investigator

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma
• Stomach Neoplasms

Intervention

Drug:
• Infigratinib
Infigratinib is a selective ATP-competitive inhibitor of fibroblast growth factor receptor (FGFR) 1-3 that inhibits FGFR downstream signaling and proliferation in human cancer cell lines with FGFR genetic alterations, significantly inhibiting the growth of several types of cancers driven by FGFR amplification, fusion and mutation.

Locations

Country	Name	City	State
China	Affiliated Hospital of Hebei University	Baoding	Hebei
China	Beijing Cancer Center	Beijing	Beijing
China	Jilin Cancer Hospital	Changchun	Jilin
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	Sichuan Cancer Hospital	Chengdu	Sichuan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Dongguan City People's Hospital	Dongguan	Guangdong
China	Guangzhou First People's Hospital	Guangzhou	Guangdong
China	The Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Guilin Medical University	Guilin	Guangxi
China	The First Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Anhui Provincial Cancer Hospital	Hefei	Anhui
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	Central Hospital Affiliated to Shandong First Medical University	Jinan	Shandong
China	Shandong Provincial Cancer Hosptial	Jinan	Shandong
China	Yunnan Cancer Hospital	Kunming	Yunnan
China	The Second Hospital Lanzhou University	Lanzhou	Gansu
China	Liuzhou People's Hospital	Liuzhou	Guangxi
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Shanxi Provincial Cancer Hospital	Taiyuan	Shanxi
China	Tianjin Medical University Cancer Institute&Hospital	Tianjin	Tianjin
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Tongji Hospital, Tongji Medical College of HUST	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
LianBio LLC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	ORR: the proportion of patients with confirmed complete response (CR) or partial response (PR), assessed by the independent review committee (IRC) according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.	Week9/17/25/33 and every 12 weeks after (up to 2 years)
Primary	Duration of response (DoR)	DoR: the duration from the first evaluation as CR or PR to the first evaluation as progressive disease (PD) or death of any cause, per RECIST v1.1 assessed by investigator (INV) and IRC.	Week9/17/25/33 and every 12 weeks after (up to 2 years)
Primary	Disease control rate (DCR)	DCR: the proportion of patients whose overall response is confirmed to be CR or PR or stable disease (SD) per RECIST v1.1, assessed by INV and IRC.	Week9/17/25/33 and every 12 weeks after (up to 2 years)
Primary	Investigator evaluated ORR	the proportion of patients with confirmed CR or PR assessed by INV according to RECIST v1.1	Week9/17/25/33 and every 12 weeks after (up to 2 years)
Primary	Progression-free survival (PFS)	the duration from the first date of treatment to the date of progression or death due to any cause, assessed by INV and IRC	Week9/17/25/33 and every 12 weeks after (up to 2 years)
Primary	Overall survival (OS)	from the first date of Infigratinib treatment until date of death.	from the first date of Infigratinib treatment until date of death.